Adamis Pharmaceuticals says yet to receive FDA response on its ZIMHI injection
Adamis Pharmaceuticals announced that as of the close of business today, Adamis has not received any notice of action from the FDA on the company's New Drug Application relating to its ZIMHI high-dose naloxone injection product for the treatment of opioid overdose. As Adamis has previously stated, in connection with its acceptance for review of the NDA the FDA previously provided a PDUFA target agency action date of October 31, 2019. However, the FDA's review processes can extend beyond, and in some cases significantly beyond, anticipated or target completion or action dates due to the timing of the FDA's review process, FDA requests for additional data, information, materials or clarification, difficulties scheduling an advisory committee meeting, FDA workload issues, extensions resulting from the submission of additional information or clarification regarding information already in the submission, or other reasons. Adamis intends to make an announcement relating to FDA action concerning the NDA after it receives a notice of action or similar communication from the agency.